Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 27
- Latest Decision
- 2026-10-02
Clearances · page 1 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K261042 | Lung Guidance | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | QJU | Class II | 2026-10-02 |
| K262412 | Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630) | Barco NV | PGY | Class II | 2026-10-02 |
| K262985 | Medical Monitor (32MD08WC) | Lg Electronics.Inc | PGY | Class II | 2026-10-02 |
| K261943 | REMEX-T(K)100C | Remedi, Inc. | IZL | Class II | 2026-10-02 |
| K261933 | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC | IYN | Class II | 2026-10-02 |
| K261612 | SwiftSight-BodyComposition | Airs Medical, Inc. | LNH | Class II | 2026-10-01 |
| K263033 | Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800) | Fussen Technology Co., Ltd. | OAS | Class II | 2026-09-30 |
| K263048 | Syngo Carbon Space (VA4) | Siemens Healthineers AG | LLZ | Class II | 2026-09-29 |
| K261225 | CAS-One IR | Cascination AG | JAK | Class II | 2026-09-29 |
| K263182 | EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound System; EVO XC10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | 2026-09-25 |
| K262548 | EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | IYN | Class II | 2026-09-25 |
| K260055 | syngo.CT Brain Quantification | Siemens Medical Solutions USA, Inc. | QIH | Class II | 2026-09-25 |
| K260114 | Align® Cover and Pad Guidance Tool | CIVCO Medical Instruments Co., Inc. | ITX | Class II | 2026-09-24 |
| K260313 | MD-6000S Bladder Scanner | MEDA Co., Ltd. | IYO | Class II | 2026-09-24 |
| K260597 | VIRTUE QA | ProNova Solutions | LHN | Class II | 2026-09-23 |
| K261874 | Syneris PACS v.1.0.1.0 | Syneris | LLZ | Class II | 2026-09-23 |
| K262442 | HipStudio Analysis | Replasia BV | LLZ | Class II | 2026-09-22 |
| K262390 | BoneXpert | Visiana | QIH | Class II | 2026-09-22 |
| K261125 | BodyTom 64 (NL4100); OmniTom Elite (NL5000) | Samsung HME America, Inc., dba NeuroLogica Corp. | JAK | Class II | 2026-09-22 |
| K261368 | Rapid Platform (R6.7) | Ischemaview, Inc. | QIH | Class II | 2026-09-21 |
| K261855 | Elucid PlaqueIQ | Elucid Bioimaging, Inc. | LLZ | Class II | 2026-09-18 |
| K261229 | SCENARIA View Phase 6.0 | Fujifilm Corporation | JAK | Class II | 2026-09-18 |
| K261865 | AerFrame Alignment Laser Box (LBV2) | Stabilix, LLC | IYE | Class II | 2026-09-16 |
| K261758 | Embrace Vision Neonatal MRI System | Aspect Imaging, Ltd. | LNH | Class II | 2026-09-16 |
| K261283 | APERTO Lucent MRI System | Fujifilm Corporation | LNH | Class II | 2026-09-16 |
| K260906 | a2z-Abdo-Triage | A2z Radiology Ai, Inc. | QAS | Class II | 2026-09-16 |
| K261623 | EchoPAC Software Only / EchoPAC Plug-in (v211) | GE Medical Systems Ultrasound and Primary Care Diagnostics | QIH | Class II | 2026-09-16 |
| K261861 | SPINEsim v1.0 | Mdsim S.A. | LLZ | Class II | 2026-09-15 |
| K261677 | Artificial Intelligence Renal Assessment (AIRA) Version 1 | Aramis Global AI Consultancies, LLC | QIH | Class II | 2026-09-15 |
| K254214 | OOOPDS | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | LLZ | Class II | 2026-09-15 |
| K261517 | qCT Lung (v1.0) | Qure.Ai Technologies Pvt. , Ltd. | QDQ | Class II | 2026-09-14 |
| K262151 | SpaceOAR Flex System | Boston Scientific Corporation | OVB | Class II | 2026-09-11 |
| K261305 | MICSI-PET | Microstructure Imaging, Inc. | KPS | Class II | 2026-09-11 |
| K254072 | BoneVue | Curvebeam AI / Curvebeam, LLC | KGI | Class II | 2026-09-11 |
| K261795 | Quicktome Software Suite | Omniscient Neurotechnology Pty, Ltd. | QIH | Class II | 2026-09-10 |
| K260879 | 4DM | INVIA, LLC | QIH | Class II | 2026-09-10 |
| K252486 | ChestView US (1.1) | Gleamer | MYN | Class II | 2026-09-09 |
| K251417 | ReVISION 2 | Argus Cognitive, Inc. | QIH | Class II | 2026-09-09 |
| K260227 | EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H | DRTECH Corporation | KPR | Class II | 2026-09-08 |
| K262060 | 3D-RD-S | Radiopharmaceutical Imaging & Dosimetry, LLC | LLZ | Class II | 2026-09-04 |
| K260525 | NextMR Spine | MRI2CT, Inc. | QIH | Class II | 2026-09-04 |
| K253836 | FCT iStream Phase 2 | Fujifilm Corporation | JAK | Class II | 2026-09-04 |
| K261313 | Vivid Explorer/Vivid Advanced/Vivid Focus | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2026-09-02 |
| K254090 | I-View® | Hologic, Inc. | MUE | Class II | 2026-09-02 |
| K262783 | RadiForce MX247W | Eizo Corporation | PGY | Class II | 2026-09-01 |
| K260758 | MAGNETOM Free.Max; MAGNETOM Free.Star | Siemens Shenzhen Magnetic Resonance , Ltd. | LNH | Class II | 2026-09-01 |
| K261718 | EZFluence (RADEZ V2) | Radformation, Inc. | IYE | Class II | 2026-08-31 |
| K260488 | MULTIX Impact; MULTIX Impact C | Siemens Medical Solutions USA, Inc. | KPR | Class II | 2026-08-31 |
| K261378 | Rayvolve AZchest | AZmed | QBS | Class II | 2026-08-28 |
| K260481 | GC85A | Samsung Electronics Co., Ltd. | KPR | Class II | 2026-08-27 |
| K260401 | EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F) | Olympus Medical Systems Corporation | PSV | Class II | 2026-08-27 |
| K260811 | Heartvue.Proton | Heartvue.ai, Inc. | QIH | Class II | 2026-08-26 |
| K260733 | MRIA Radiation Therapy Information System (MRIA) | Manteia Technologies Co., Ltd. | IYE | Class II | 2026-08-26 |
| K261595 | Ceevra Reveal 4 | Ceevra, Inc. | QIH | Class II | 2026-08-25 |
| K254027 | Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90) | Sonoscape Medical Corp. | IYN | Class II | 2026-08-24 |
| K262127 | DS Core CBCT Anatomy | Dentsply Sirona | QIH | Class II | 2026-08-21 |
| K260584 | BoneMRI | Mriguidance B.V. | QIH | Class II | 2026-08-21 |
| K253726 | uAngio AVIVA CX | Shanghai United Imaging Healthcare Co., Ltd. | OWB | Class II | 2026-08-21 |
| K262622 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | LNH | Class II | 2026-08-19 |
| K261413 | EXTRON 3;EXTRON 6 | DRTECH Corporation | OWB | Class II | 2026-08-19 |
| K261641 | Lower Limb AI (LLAI) | AI Planning Logic, Inc. | QIH | Class II | 2026-08-18 |
| K261500 | KBA3D (v2.4.0) | S.M.A.I.O | LLZ | Class II | 2026-08-17 |
| K254250 | MagicScan-1.5, GreenMR Serenity 1.5T | Xingaoyi Medical Equipment Co.,Ltd | LNH | Class II | 2026-08-17 |
| K262449 | AdvaView | ADVAHEALTH SOLUTIONS, LLC | LLZ | Class II | 2026-08-14 |
| K262452 | AutoContour (RADAC V6) | Radformation, Inc. | QKB | Class II | 2026-08-14 |
| K260898 | Transpara (2.1.0) | Screenpoint Medical B.V. | QDQ | Class II | 2026-08-14 |
| K253808 | AIR Recon DL | GE Medical Systems | LNH | Class II | 2026-08-13 |
| K260086 | CadAI-B Dx | BeamWorks, Inc. | QDQ | Class II | 2026-08-12 |
| K261170 | BA-004CC | Fujifilm Corporation | ITX | Class II | 2026-08-12 |
| K261916 | NeuroQuant PET | Cortechs Labs, Inc. | LLZ | Class II | 2026-08-12 |
| K254143 | EM-TECH Passive Ultrasound Probe Strap | EM-TECH Solutions, Inc. | ITX | Class II | 2026-08-10 |
| K253794 | Prostate Core | Lucida Medical, Ltd. | QIH | Class II | 2026-08-10 |
| K254205 | Zenition 30 | Philips Medical Systems Nederland B.V. | OWB | Class II | 2026-08-07 |
| K252571 | mdprostate | Mediaire GmbH | QIH | Class II | 2026-08-07 |
| K261668 | Venue Go | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC | IYN | Class II | 2026-08-07 |
| K261059 | Overjet Multi-Image Caries and Charting Assist | Overjet, Inc. | MYN | Class II | 2026-08-06 |
| K253902 | RealGUIDE | 3DIEMME SRL | QIH | Class II | 2026-08-04 |
| K262311 | Alturion Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | IYN | Class II | 2026-08-04 |
| K260236 | XLITE | GEMSS HEALTHCARE CO., LTD. | IZL | Class II | 2026-08-03 |
| K261856 | Halcyon, Ethos Radiotherapy System (5.0) | Varian Medical Systems, Inc. | IYE | Class II | 2026-08-03 |
| K260852 | MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure | Siemens Healthineers AG | LNH | Class II | 2026-07-31 |
| K253800 | 0909FCE, 0909FCE-HS | Rayence Co., Ltd. | MQB | Class II | 2026-07-31 |
| K253835 | Affinity | Hermes Medical Solutions AB | QIH | Class II | 2026-07-31 |
| K260607 | Shield System (Siemens 30x40) | Radiaction , Ltd. | OWB | Class II | 2026-07-31 |
| K261331 | I-Genius (100019400) | Esaote, S.p.A. | LNH | Class II | 2026-07-31 |
| K260936 | RadioViewAI | Neurocareai, Inc. (Dba Savelife.Ai) | LLZ | Class II | 2026-07-31 |
| K261288 | Handheld Ultrasound Scanner | IMGFAX CO., LTD. | IYN | Class II | 2026-07-30 |
| K260980 | cmAngio® V2.0 | Curemetrix, Inc. | QIH | Class II | 2026-07-30 |
| K262330 | dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T | Philips Medical Systems Nederland B.V. | MOS | Class II | 2026-07-30 |
| K261835 | LOGIQ Focus | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | 2026-07-30 |
| K260161 | SmartGuide Disposable Guides and Grids | UC-CARE , Ltd. | ITX | Class II | 2026-07-30 |
| K261210 | Cleerly Plaque | Cleerly, Inc. | QIH | Class II | 2026-07-29 |
| K260588 | Cleerly LABS | Cleerly, Inc. | LLZ | Class II | 2026-07-29 |
| K260303 | See-Mode Augmented Reporting Tool, Breast (SMART-B) | See-Mode Technologies Pty, Ltd. | QDQ | Class II | 2026-07-28 |
| K261412 | V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System; | Samsung Medison Co., Ltd. | IYN | Class II | 2026-07-28 |
| K261427 | uMI Panvivo (uMI Panvivo M) | Shanghai United Imaging Healthcare Co., Ltd. | KPS | Class II | 2026-07-28 |
| K253450 | BodyTom Elite (NL4000) | NeuroLogica Corp., a Samsung Company | JAK | Class II | 2026-07-28 |
| K261211 | Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | IYN | Class II | 2026-07-27 |
| K262474 | ND Needle Guidance System | Accurate Access, LLC | ITX | Class II | 2026-07-27 |
| K253452 | Accuro 3S | Rivanna Medical, Inc. | IYO | Class II | 2026-07-24 |
14,721 clearances in the Radiology panel. Data: openFDA.